A Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold

A Randomized, Single-Center, Patient & Evaluator-Blind, Matched Pairs, Active-Controlled Design Confirmatory Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07150273

Enrollment

Registered

2025-09-02

Start date

2016-02-23

Completion date

2017-07-28

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolabial Fold

Brief summary

A 48-week, single-center, randomized, patient & evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design

Interventions

DEVICEUNIVELO Sub-Q 2mL

Test device

DEVICERestylane Sub-Q 2mL

Comparator Device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects who desire temporary improvement of both nasolabial folds and who has rated 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) (the rating does not have to be the same for both sides) * Subjects who have agreed to discontinue all dermatological treatments or procedures, including those for facial wrinkles improvement in the facial area, during the clinical trial period * Subjects capable of understanding and complying with directions and who can participation for the full duration of the clinical trial period * Subjects who have voluntarily decided to participate in the clinical trial and have given written consent by signing the subject informed consent form

Exclusion criteria

* Subjects who have been administered an antithrombotic agent (with the exception of low dosage aspirin (100mg, maximum 300mg/day)) within 2 weeks of the date of the screening * Subjects who have had a history of any bleeding disorder, in the past or the present

Design outcomes

Primary

Measure	Time frame	Description
Wrinkle Severity Rating Scale (WSRS)	24 weeks	Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)

Secondary

Measure	Time frame	Description
Wrinkle Severity Rating Scale (WSRS)	8 weeks, 16 weeks, 36 weeks, 48 weeks	Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
Global Aesthetic Improvement Scale (GAIS)	8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks	Measure improvement status of wrinkle from score of -1 (worse) to 3 (very much improved)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026